1) FIELD OF THE INVENTION
The field of this invention relates to a alignment verification device for a rotating shaft, and more particularly to an alignment verification device for a rotating shaft of a dissolution apparatus which uses a rotating shaft to apply a turbulence to a liquid within which is located a pill.
2) DESCRIPTION OF THE PRIOR ART
Drugs are commonly manufactured and sold in pill form. Pills generally refer to tablets, capsules and caplets. Pills are constructed to release drugs into the body over a period of time. It is generally not desirable to release all of the drug immediately into the body. Therefore, it is necessary before a particular drug is marketed to incorporate that drug in pill form and then to ascertain the amount of drug that would be released into the body over a preset period of time.
There are conventionally available pieces of equipment that are used to ascertain the amount of release of a drug into the stomach of a body such as a human body. Generally these pieces of equipment utilize a plurality of flasks each of which contain a quantity of the liquid. Generally the liquid will essentially duplicate the liquid that is commonly contained within the stomach of the body. The most common type of body would be a human body. However, it is certainly within the scope of this invention that the equipment could be utilized to test absorption rates for other bodies such as horses, cows, dogs, cats and other animals.
Into each flask there is deposited a pill of the drug. A mixing device is inserted within each flask and is to be moved in a manner to essentially duplicate the turbulence that generally would be created naturally within the stomach of the body. Aliquots are removed from each flask at preset periods of time with these aliquots to be tested to ascertain the amount of the drug that has been dissolved within each flask. It is common that before a drug is given permission to be sold that a substantial number of such tests are performed with an average being calculated so that the precise dissolving nature of the drug is ascertained.
In order to precisely ascertain the amount of drug that is absorbed, the equipment that is used will subject the flask to a precisely known temperature. Also the mixing device that is placed within each flask must precisely mix the liquid within each flask in exactly the same manner. Therefore, it is important that the mixing device be centrally located within the flask. It is also important that the mixing device not be skewed in any angle but is located in direct alignment with the longitudinal center axis of the flask.
It is common that such testing apparatuses are able to perform a number of such tests simultaneously. Therefore, before such tests are initiated, it is necessary to ascertain that the position of the mixing paddle for each flask is precisely positioned along the longitudinal center axis of its flask. In the past it was common to just "eyeball" the mixing paddle so that the rotating shaft of the mixing paddle would be in substantial alignment with the longitudinal center axis of the flask. However, under current practice, the eyeballing technique is not sufficient.
Additionally, the mixing paddle would be measured by some kind of simple measurement device again to ascertain that the rotating shaft coincides with the longitudinal center axis of the flask. However, at the current time, these simple types of measuring devices are not sufficient to ascertain accurate rates of dissolution of the pill.
There is currently available dissolution testing equipment where a concerted effort is being made so that each test that is performed within each flask is subjected to precisely the same conditions as in each other flask. However, prior to the present invention, there has not been known to Incorporate a device that is designed specifically to calibrate this equipment to insure that each test that is performed within each flask is identically performed.